Diurnal Variations of Cerebral MetaboliteDyn24NCT03497832
Diurnal Variations of Brain Metabolite Concentrations in 1H-MRS
A study testing magnetic resonance spectroscopy (MRI) in people with Diurnal Variations of Cerebral Metabolite, run by Poitiers University Hospital at 1 site in France.
Trial summary
Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI) technique. It allows the quantification of cerebral metabolite concentrations. Currently, MRS-1H is used regardless of the examination schedule. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diurnal Variations of Cerebral Metabolite
- What is being tested?
- magnetic resonance spectroscopy (MRI)
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2018to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-45 years
- Voluntary subjects, without guardianship or curatorship or subordination
- Subjects benefiting from a Social Security scheme or benefiting from it through a relative
- Informed and signed consent by the subject after a clear and fair information of the study
Who cannot join
- Age < 25 years or > 45 years
- Current participation in another clinical research study
- Subjects not benefiting from a Social Security scheme or not benefiting from it through a relative
- Subjects benefiting from enhanced protection, namely minors, pregnant women, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and patients in emergencies.
- Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy )
- Neurological, psychiatric, endocrinological, cardiac, pulmonary disorders.
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- Unbalanced sleep disorders: untreated obstructive sleep apnea, insomnia, major delayed or advanced sleep phase, shift work with irregular rhythms.
- Taking any type of treatment, except oral contraception for women.
- Any contraindication to performing an MRI examination: pregnancy, ocular metallic foreign body (accidental blisters or others); Tattooing for a part of the face or skull, pacemaker (cardiac simulator), neurostimulator, cochlear implants and in general any implanted medical equipment; metallic cardiac valve, vascular clips formerly implanted on cranial aneurysm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diurnal Variations of Cerebral Metabolite Concentrations in Proton Magnetic Resonance Spectroscopy
Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI) technique. It allows the quantification of cerebral metabolite concentrations. Currently, MRS-1H is used regardless of the examination schedule. However, it is not possible to say if the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy subjects.
Moreover, the investigators also want to investigate the association between choline concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the white matter of the centrum ovale. The results obtained from this objective will allow to obtain reference values of an estimate of the association between Cho concentrations and AF values in healthy subjects. These data are intended to improve the diagnostic and therapeutic management of patients with neurological pathologies.
Read the detailed description
Currently, it is not possible to say if the brain metabolite concentrations are stable over 24 hours in 1H-MRS. Few studies, with small samples (< 10 subjects), have investigated this point. Their conclusions remain inconsistent. Without an available study with sufficient statistical power, it is not currently possible to state that concentrations of brain metabolites are stable over 24 hours. Therefore, it is not possible to formally conclude on differences in concentrations of metabolites between a healthy subject and a patient.
It is known that the human circadian rhythm leads to changes on many parameters such as hormonal secretions (TSH, cortisol, melatonin, growth hormone, and carbohydrate metabolism) and body temperature. It therefore seemed relevant to choose 3 of the most critical periods of the human circadian rhythm (7:30, 13:30 and 18:00) to assess the diurnal variations of cerebral metabolite in 1H-MRS. The DTI sequence will only be performed once.
The study will take place at the University Hospital of Poitiers, in the department of Medical Imaging. 3 appointments are planned: the pre-inclusion one D0, the inclusion one D1 including the signature of the consent, and the D3 one for the realization of the 3 MRIs at 7:30 am, 1:30 pm and 6 pm. Each MRI scan lasts an average of 20 minutes.
- Being tested
- magnetic resonance spectroscopy (MRI)
- Keywords
- Proton Magnetic Resonance Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance spectroscopy (MRI)Other
Each healthy subject will get 3 MRI examinations at 7:30, 13:30 and 18:00. Each MRI scan lasts an average of 20 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of diurnal variations of brain metabolite concentrations in 1H-MRS
The primary outcome is to describe the diurnal variation of N-acetylaspartate (NAA), choline (Cho), creatine (Cr), gamma-aminobutyric acid (GABA) and glutamate at 7:30 am, 1:30 pm and 6 pm, in the basal ganglia, the anterior and posterior cingulate cortex, the insular cortex, the white matter in healthy subjects. The data will be collected at D3.
Measured: 1 day
Secondary outcomes (1)
investigation of the association between Cho concentrations and AF values in the white matter of the centrum ovale.
investigation of the association between Cho concentrations and AF values in the white matter of the centrum ovale.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start2 May 2018
- Primary completion2 May 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diurnal Variations of Cerebral MetaboliteStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497832
- Sponsor's protocol ID
- 2017-A02804-49
- Acronym
- Dyn24
- Status last verified
- Dec 2022
- First submitted
- 9 Mar 2018
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Variations of Cerebral Metabolite Concentrations in Proton Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT03497832
- Acronym / sponsor ID
- Dyn24 / 2017-A02804-49
- Keywords
- Proton Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI) technique. It allows the quantification of cerebral metabolite concentrations. Currently, MRS-1H is used regardless of the examination schedule. However, it is not possible to say if the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy subjects.
Moreover, the investigators also want to investigate the association between choline concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the white matter of the centrum ovale. The results obtained from this objective will allow to obtain reference values of an estimate of the association between Cho concentrations and AF values in healthy subjects. These data are intended to improve the diagnostic and therapeutic management of patients with neurological pathologies.
Detailed description
Currently, it is not possible to say if the brain metabolite concentrations are stable over 24 hours in 1H-MRS. Few studies, with small samples (< 10 subjects), have investigated this point. Their conclusions remain inconsistent. Without an available study with sufficient statistical power, it is not currently possible to state that concentrations of brain metabolites are stable over 24 hours. Therefore, it is not possible to formally conclude on differences in concentrations of metabolites between a healthy subject and a patient.
It is known that the human circadian rhythm leads to changes on many parameters such as hormonal secretions (TSH, cortisol, melatonin, growth hormone, and carbohydrate metabolism) and body temperature. It therefore seemed relevant to choose 3 of the most critical periods of the human circadian rhythm (7:30, 13:30 and 18:00) to assess the diurnal variations of cerebral metabolite in 1H-MRS. The DTI sequence will only be performed once.
The study will take place at the University Hospital of Poitiers, in the department of Medical Imaging. 3 appointments are planned: the pre-inclusion one D0, the inclusion one D1 including the signature of the consent, and the D3 one for the realization of the 3 MRIs at 7:30 am, 1:30 pm and 6 pm. Each MRI scan lasts an average of 20 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 25-45 years
- Voluntary subjects, without guardianship or curatorship or subordination
- Subjects benefiting from a Social Security scheme or benefiting from it through a relative
- Informed and signed consent by the subject after a clear and fair information of the study
Key exclusion criteria (9 listed)
- Age < 25 years or > 45 years
- Current participation in another clinical research study
- Subjects not benefiting from a Social Security scheme or not benefiting from it through a relative
- Subjects benefiting from enhanced protection, namely minors, pregnant women, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and patients in emergencies.
- Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance spectroscopy (MRI)Each healthy subject will get 3 MRI examinations at 7:30, 13:30 and 18:00. Each MRI scan lasts an average of 20 minutes. | Other | – |
Primary outcome
Description of diurnal variations of brain metabolite concentrations in 1H-MRS
Time frame: 1 day
The primary outcome is to describe the diurnal variation of N-acetylaspartate (NAA), choline (Cho), creatine (Cr), gamma-aminobutyric acid (GABA) and glutamate at 7:30 am, 1:30 pm and 6 pm, in the basal ganglia, the anterior and posterior cingulate cortex, the insular cortex, the white matter in healthy subjects. The data will be collected at D3.
1 secondary outcome
investigation of the association between Cho concentrations and AF values in the white matter of the centrum ovale.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance spectroscopy (MRI) in people with Diurnal Variations of Cerebral Metabolite, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of diurnal variations of brain metabolite concentrations in 1H-MRS (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.